# K151918: Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Incorporated
- Decided: Feb 11, 2016 after 213 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K974780 (1998). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113703: Bausch + Lomb Nesofilcon a Contact Lens, Bausch & Lomb, Incorporated (2012) Summary page 4.
- K132715: Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact Lens, Bausch & Lomb, Incorporated (2013) Summary page 4.
- K143632: Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens, Bausch & Lomb, Incorporated (2015) Summary page 4.

## Indications for use
Spherical: The Bausch + Lomb Lomb Biotrue® ONEday (nesofilcon A) Contact Lens with NaturMoist is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive astigmatism up to 2.00 diopters or less, that does not interfere with visual acuity. The lens is to be prescribed in spherical powers ranging from +20.00D to -20.00D. Multifocal: The Bausch + Lomb Biotrue® ONEday for Presbyopia (nesofilcon A) Soft (Hydrophilic) Contact Lens with NaturMoist is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters with add power ranging from +0.75D to +5.00D. Toric: The Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens with NaturMoist is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters for daily wear. The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.

Source page: https://510kreport.com/device/K151918
Methodology: https://510kreport.com/methodology